Implant for Walking After Incomplete SCI

NCT06965127 | Recruiting DMC FDA Device

• 2 other identifiers: 1802378CDMRP-SC230198
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This is a device study that will evaluate the effect of an implanted stimulator on improving walking in people with incomplete spinal cord injury. There are two phases in the study: 1) Screening - this phase determines if the individual is a good candidate to receive an implanted system, 2) Implantation, controller development, and evaluation - this phase includes implanting the device and setting the individual up for system use, creating controllers for walking, and evaluating the effect of the device over a couple years.

Conditions

Spinal Cord Injury (SCI); Gait

Keywords

neuroprosthesis; implanted device

Outcome Measures

Primary Outcomes (1)

• Difference in maximum walking distance

  The maximum walking distance is a measure of how far the participant can walk within a single bout over an unconstrained period of time. The measure is used to assess whether endurance and walking capacity improve. The difference between walking with and without the system turned on determines if the system improves walking capacity. Users serve as their own concurrent controls.

  Immediately after the participant is fully trained to use their implanted system

Secondary Outcomes (2)

• Difference in spinal cord injury - functional ambulation inventory (SCI-FAI)

  Immediately after the participant is fully trained to use their implanted system

• Difference in Home and community mobility

  Baseline and Immediately after the participant is fully trained to use their implanted system

Study Arms (1)

Implantation, controller development and evaluation

EXPERIMENTAL

This phase includes installing the device and setting the individual up for use of the system and evaluating the effect of the system on walking ability.

Device: NNP-LE

Interventions

NNP-LE DEVICE

Networked NeuroProsthesis - Lower Extremity Configuration (NNP-LE) measuring physiologic command signals and delivering neural stimulation to intramuscular and nerve cuff electrodes for trunk and leg muscle assistance.

Implantation, controller development and evaluation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 18-75
• Non-ventilator dependent paralysis resulting from injuries such as: cervical/thoracic spinal cord injuries affecting the trunk and/or lower limbs
• Impairment classification of AIS B, C, or D (preservation of sensation and/or some motor function) with weakness in trunk and/or lower extremity muscles
• Unable to walk faster than 0.8m/s during a 10m walk test
• Gait deviation such as reduced peak hip, knee, and/or ankle range of motion during stance or swing phases due to motor impairment
• Time post injury greater than six months
• Innervated and excitable lower extremity and trunk musculature
• Adequate social support and stability
• Willingness to comply with follow-up procedures
• Appropriate body habitus (height and weight within acceptable limits as determined by study physician)
• Neurologically stable as determined by a physician

You may not qualify if:

• Significant fracture risk or history of spontaneous fractures
• History of heterotopic ossification at the hip, knee, or ankle
• Non-English speaking
• Insufficient upper extremity function to use an assistive device (e.g. walker or cane)
• Females who are pregnant
• Current pressure injury that would be exacerbated by study activities
• Uncontrolled spasticity that would interfere with study activities
• Significant range of motion limitations that would compromise study activities
• History of vestibular dysfunction, balance problems, or spontaneous falls
• Disorder or condition that require MRI monitoring
• Acute and/or untreated orthopedic issues that would prevent weight bearing or exercising implanted muscles such as a dislocation or fracture
• Acute and/or chronic medical problems left untreated or not controlled that would increase risk by using stimulation such as cardiac abnormalities, immunological/pulmonary/renal/circulatory compromise
• Uncontrolled diabetes or hypertension
• Presence of a demand pacemaker, cardiac defibrillator, or neuroprosthesis system with components in the legs
• Any other medical or psychological condition that would be a contraindication

Sponsors & Collaborators

• Louis Stokes VA Medical Center: lead
• MetroHealth Medical Center: collaborator
• CDMRP: collaborator

Study Sites (1)

Louis Stokes Cleveland Veterans Affairs Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Nathan Makowski, PhD

  MetroHealth System, Ohio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Lombardo, MPT

CONTACT

216-791-3800; lisa.lombardo2@va.gov

Maura Malenchek, PTA

CONTACT

216-791-3800; maura.malenchek@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 11, 2025
• Study Start: August 27, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2031
• Last Updated: November 26, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: data will become available after study completion
• Access Criteria: de-identified data will be available to anyone with access to the ODC-SCI repository

Locations

US (1)